Overview

This trial is active, not recruiting.

Conditions congenital hyperinsulinism, hyperinsulinism, persistent hyperinsulinemic hypoglycemia of infancy, chi, phhi
Treatments f-dopa, pet scan
Phase phase 2
Sponsor Children's Hospital of Philadelphia
Collaborator University of Pennsylvania
Start date December 2004
End date December 2008
Trial size 105 participants
Trial identifier NCT00674440, 2004-3-3683, 802337, FD-R-003457-01

Summary

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and will be scheduled for surgery. Eligible children in this arm will PET imaging with F-DOPA prior to surgery.
f-dopa 18F-labeled L-fluorodeoxyphenylalanine
0.08-0.16 mCi/kg once
pet scan
(Experimental)
Children diagnosed with hyperinsulinism who have had partial pancreas removal but still display signs of hyperinsulinism. Eligible children in this arm may have PET imaging with F-DOPA.
f-dopa 18F-labeled L-fluorodeoxyphenylalanine
0.08-0.16 mCi/kg once
pet scan
(Experimental)
Children diagnosed with hyperinsulinism who are successfully managed with diazoxide, octreotide, other medications,and/or tube feedings. Eligible children in this arm will PET imaging with F-DOPA.
f-dopa 18F-labeled L-fluorodeoxyphenylalanine
0.08-0.16 mCi/kg once
pet scan

Primary Outcomes

Measure
The ability of FDOPA PET to identify forms of hyperinsulinism that may be cured by surgery: focal forms.
time frame: one year

Secondary Outcomes

Measure
Assess safety of F-DOPA PET.
time frame: one year

Eligibility Criteria

Male or female participants up to 18 years old.

Inclusion Criteria: - Any age, but primarily infants 0-6 months. - Children with confirmed diagnosis of congenital hyperinsulinism. Exclusion Criteria: - Cases in which surgery will not be considered by parents or guardians.

Additional Information

Official title Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan
Principal investigator Chaitanya R. Divgi, MD
Description For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.